Hormone replacement therapy (HRT) has been used successfully to treat a variety of conditions, such as osteoporosis, increased risk of cardiovascular disease in post-menopausal women and climacteric symptoms, such as hot flashes, decreased libido and depression. However, HRT with estradiol (E2), either alone or in combination with progestin, can lead to undesirable effects. In fact, a recent Women's Health Initiative (WHI) study was abruptly halted when preliminary results showed that HRT was associated with a 35% increased risk of breast cancer.
Breast cancer can be treated or prevented by using a so-called selective estrogen receptor modulator (SERM), such as tamoxifen. (Before the approval of tamoxifen, breast cancer treatment of pre-menopausal women often included removing the ovaries in order to reduce the cancer-stimulating effect of estrogen.) Tamoxifen appears to selectively block the cancer-inducing effects of estrogen in breast tissues of pre-menopausal women. Another SERM, raloxifene, has been approved for treatment of osteoporosis as an alternative to estrogen replacement. In addition to selectively inducing estrogenic effects in bone tissue, long-term administration of raloxifene was also shown to be associated with reduction in the rate of breast cancer in the Multiple Outcomes of Raloxifene Evaluation (MORE) study.
While SERMs such as tamoxifen and raloxifene provide selective reduction in estrogen's cancer-inducing effects in the breast, they are not without their risks. For example both tamoxifen and raloxifene therapy have been associated with increased incidence of hot flushes; and tamoxifen therapy has been shown to increase the risk of uterine (endometrial) cancer.
Despite the success of estrogen replacement therapy in treating osteoporosis, coronary heart disease and climacteric symptoms, and despite the success of using SERMs like tamoxifen and raloxifene in treating breast cancer and osteoporosis, there remains a need for compositions having estrogenic properties. Additionally, given the increasing cost of producing drug compounds, there is a need for additional estrogenic compositions that may be obtained from natural sources.
Various cultivars of white mulberry (Morus alba L.) have been grown throughout the world for a wide variety of purposes. It generally grows as a tree or a shrub. In the Orient, it has been grown for centuries for its leaves, which are used as silk worm fodder, and secondarily as fodder for herbivorous livestock. In the United States, cultivation is believed to have been first attempted by Shakers, who intended to use the leaves as fodder for silk worms, however silk worm cultivation failed. White mulberry is now grown in the United States as an ornamental, as a wind break for edging fields, and for its fruit (although the fruit of black mulberry is preferred over that of white mulberry). In some parts of the southern United States, it is considered an invasive plant. It is readily adapted to growing in a number of soil types, elevations and latitudes. There is no known report of using extracts of Morus alba L. as estrogenic compositions.
There is a need for estrogenic compositions that are readily obtained from natural sources. There is also a need for methods of making such compositions. There is also a need for methods of using such estrogenic compositions.